ServiTecno will participate in the study day scheduled for next week Microbiology and Annex 1, the EU GMPs section which regulates the manufacture of sterile products.
Below is the program of the day and the links to register and participate.
Microbiology and Annex 1 2020 – Thursday 19 May 2022 (10.00 am – Four Points by Sheraton Milan Center – Sala Michelangelo)
Chairman Francesco Boschi – Sr. Manager Technical Services – Global Microbiology and Aseptic Support Team (MAS), Pfizer
Di what will we talk about? Annex 1 is the EU GMPs section which regulates the manufacture of sterile products.
The current revision has been in effect since 2009; in 2017 EMA released a new draft version for comments.
A new version followed in 2020, issued to facilitate further consultation and receipt of comments from "targeted stakeholders", including ISPE.
The publication of the final version of the document is expected by Q3 2022.
Considering that many of the contents will be confirmed in the final version and that it is the first complete revision of the Annex, the Italian affiliate of ISPE has started a Working Group with the aim of understanding and interpreting the contents and evaluating the impact and implications of the same on the Quality Systems and on the new and existing facilities.
During the day of May 19, the following sector professionals will intervene:
- Gilberto Dalmaso – Veltek Associates
- Renato Picchi – PharmaProcess
- Andrea Pranti – GlaxoSmithKline
- Paolo Montapponi – Thermofisher
- Cristina Viganò – IBSA
- Carla Colombo – Recipharm
- Serenella Bruschi –
- Angelini Lucia Ceresa – Charles River
The sponsors of this study day are
